BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500

• K Number: K033239
• Device Name: BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
• Manufacturer: TUNG KENG ENTERPRISE CO., LTD.
• Date Cleared: 2003-11-12 ( 37 days)
• Product Code: INI
• Regulation Number: 890.3800
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: K013763

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Device Description

The Be-Mobile 4-Wheeled Electric Scooter DK S500 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The provided text is a 510(k) summary for the Be-Mobile 4-Wheeled Electric Scooter, DK S500. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

Here's why and what information is available:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. The document does not describe specific performance-based acceptance criteria for the scooter in terms of clinical outcomes or diagnostic accuracy. Instead, it relies on demonstrating that the new device meets established safety and performance standards and is substantially equivalent to a legally marketed predicate device.

• Reported Device Performance (from the document): The document states:

  • "The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured."
  • The device underwent "Performance Testing" to standards: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods).

2. Sample size used for the test set and the data provenance:

• Not Applicable. No test set or clinical data is described in terms of a sample size. The "performance testing" referred to are likely engineering and safety tests on the device itself, not a study involving human subjects or clinical data in the way implied by the question.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. As no clinical "test set" relying on a ground truth is described, there's no mention of experts or their qualifications in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No adjudication method is described as there is no clinical test set requiring such a process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. An MRMC study is completely irrelevant to this device (an electric scooter). The device does not involve "readers" or "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is an electric scooter, it does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. Ground truth in the context of clinical or diagnostic performance assessment is not relevant for this device. The "truth" here relates to compliance with engineering standards and safe operation, as demonstrated by the listed performance tests.

8. The sample size for the training set:

• Not Applicable. This device (an electric scooter) does not involve machine learning algorithms that would require a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

Summary of what the document DOES tell us about the device's validation:

• Mechanism of Validation: The primary validation method for this 510(k) submission is demonstrating substantial equivalence to a previously legally marketed device (WU'S 4-WHEELED NEO SCOOTER WT-L4, K013763).
• Key Differences and Justification: The main differences identified are the type of electronic controller, overall dimensions, tire size, and weight. The submitter argues that the different controller (Dynamic Rhino DS72k vs. Curtis PMC) and physical appearance differences are not safety aspects and therefore do not negate substantial equivalence.
• Safety Assurance: The document emphasizes that the "electronic systems between two devices are the same and all passed by the UL certificated," ensuring the same safety level.
• Performance Standards: The device was tested against recognized industry standards for electrically powered wheelchairs, scooters, and their chargers (listed in section 1 above).

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).